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SNE / Rheumatology

Type of position:  Seconded National Expert
Shift Type:  28 October 2021 23:59 CET

Type of position: Seconded National Expert 

Job title: SNE / Rheumatology

Deadline for applications: 28 October 2021 23:59 CET 

 

The European Medicines Agency is a decentralized body of the European Union with all its offices and Headquarters based in Amsterdam, the Netherlands. Its core responsibility is the protection and promotion of public health through the evaluation and supervision of medicines.

 

We are looking for National experts on secondment. This means staff from other European public-sector bodies can work at the European Medicines Agency (EMA) for short periods of time through the national expert on secondment (SNE) programme. The aim of this programme is to enhance and develop the relationship between European public administrations.

 

SNEs serve a dual role: they bring their expertise to EMA and take back to their home administration the knowledge acquired during their period of secondment. SNEs remain in the service of their employer. Secondment is not equivalent to employment, nor does it lead to employment by EMA. Periods of secondment may last between six months and two years. This is renewable once or more, up to a total of four years.

 

This announcement is governed by the Rules governing the secondment of national experts. For further information please visit our Careers portal.

 

 

About this role

 

As a Seconded National Expert in the Human Medicines Division, Scientific Evidence Generation Department, you will be responsible for provision of clinical expertise in the area of rheumatology (and clinical immunology) across the medicine life-cycle, through contribution to development support and evaluation activities.

 

Job description

 

As a Seconded National Expert, your activities will include at least some of the following:
 

Provision of clinical expertise in the area of rheumatology (and clinical immunology) across the medicine life-cycle, through contribution to development support and evaluation activities such as:


•    Scientific input for the product related issues or questions related to the therapeutic area (TA) “rheumatology” (including clinical immunology), irrespective of type of procedure (marketing authorisation including post-authorisation; scientific advice; paediatric development; orphan development). 
•    Providing technical and scientific support to groups of experts. 
•    Develop a training curriculum in order to strengthen the role of the scientific secretariat and build capabilities. Delivery to EMA staff and the network (through EU-NTC).

 

Management of requests for scientific advice, protocol assistance, qualification of novel methodologies, EMA/FDA parallel scientific advice and EMA/HTA parallel consultation in accordance with agreed timelines:


•    Management of requests for scientific advice. Co-ordination of scientific advice in collaboration with SAWP Rapporteurs, members of the Scientific Advice Working Party (SAWP) and the Qualification Teams, Patient Representatives, European Experts, the Chairperson and Secretaries of other Working Parties, the internal network of Scientific Officers, the FDA, and the EU HTA bodies.
•    Ensuring consistency between scientific advice, guidelines and marketing authorisations. 

 

Stakeholder interactions:


•    Support of the collaboration with EU and international stakeholders through workshops, projects and initiatives relevant to the TA / Scientific Advice. 
•    Liaising with patient representatives in the course of scientific advice procedures.
•    External scientific output including in peer-reviewed journals and conferences and in collaboration with Academia.

 

Communication and professional contacts:


•    Daily internal communication and interaction related to the management of the procedures with scientific administrators across the Agency and the extended product team members. 
•    Interaction with Rapporteurs and assessors on (non-) clinical, procedural and administrative aspects as well as regulatory science considerations, providing expertise as appropriate. 
•    Contact point for Applicants, MAHs, and all other external stakeholders. 
•    Responsible for maintenance of established channels for dialogue with network of experts (applicable SAGs, Expert group meetings, working parties).

 

Assessment Criteria

 

Eligibility criteria:  

•    enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;
•    a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);
•    be currently employed in the public sector (such as a university, research institute, public hospital or regulatory body) in a European Union (EU) Member State.
 

Essential criteria:

•    A degree in medicine and a formal specialisation or more than 5 years clinical experience in rheumatology/clinical immunology
•    Excellent communication and presentation skills and ability to interact professionally within a multicultural environment.

 

Desirable criteria:

•    Proven publication record in the area of rheumatology/clinical immunology
•    Teaching experience and/or interest in teaching and supporting the development of others
•    Excellent co-ordination skills and strong sense of ownership of tasks and responsibilities

______________________________________________________________________________________________________

 

Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands

Telephone +31 (0)88 781 6000 - Email recruitment@ema.europa.eu

 

© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.


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